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EP1857809A1 - Procédé de mesure de quantité d'enduction et procédé d'évaluation du comportement d'élution - Google Patents

Procédé de mesure de quantité d'enduction et procédé d'évaluation du comportement d'élution Download PDF

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Publication number
EP1857809A1
EP1857809A1 EP06713343A EP06713343A EP1857809A1 EP 1857809 A1 EP1857809 A1 EP 1857809A1 EP 06713343 A EP06713343 A EP 06713343A EP 06713343 A EP06713343 A EP 06713343A EP 1857809 A1 EP1857809 A1 EP 1857809A1
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EP
European Patent Office
Prior art keywords
coating
near infrared
long
measurement
absorption
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP06713343A
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German (de)
English (en)
Other versions
EP1857809A4 (fr
Inventor
Makoto c/o Kawashima Industrial Park Eisi Co. Ltd. YOKOYAMA
Koji c/o Kawashima Industrial Park Eisai Co. Ltd. UKAI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eisai R&D Management Co Ltd
Original Assignee
Eisai R&D Management Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eisai R&D Management Co Ltd filed Critical Eisai R&D Management Co Ltd
Publication of EP1857809A1 publication Critical patent/EP1857809A1/fr
Publication of EP1857809A4 publication Critical patent/EP1857809A4/fr
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005—Coating of tablets or the like
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/3563—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light for analysing solids; Preparation of samples therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
    • G01N21/359—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light using near infrared light
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
    • G01B11/00—Measuring arrangements characterised by the use of optical techniques
    • G01B11/02—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness
    • G01B11/06—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness for measuring thickness ; e.g. of sheet material
    • G01B11/0616—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness for measuring thickness ; e.g. of sheet material of coating
    • G01B11/0625—Measuring arrangements characterised by the use of optical techniques for measuring length, width or thickness for measuring thickness ; e.g. of sheet material of coating with measurement of absorption or reflection
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
    • Y10T428/2991—Coated
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]

Definitions

  • the present invention relates to a method of measuring the coating quantity when a coating liquid is applied to granules, tablets or the like, the measurement being carried out using the absorption or scattering of light in the 800 to 1100 nm wavelength range by an additive that has been coated on a coating target, and relates to a method of predicting the dissolution behavior of a pharmacologically effective component from the granules or the like, based on the coating quantity determined by the aforementioned method.
  • Various single- or multilayer coatings may be applied to oral formulations, such as granules or tablets, for the purpose of, for example, quality preservation, taste masking, or controlling the dissolution properties, e.g., enteric dissolution behavior, sustained-release behavior.
  • Such coatings are typically applied by a method such as film coating, powder coating, or press coating. Since slight differences in coating quantity have an influence on, for example, the characteristics of a formulation, quality, and so forth, it is necessary from a quality management perspective to exercise fairly rigorous control on the quantity of a coating on the coating target, e.g., granules or uncoated tablets.
  • a method heretofore used to measure the coating quantity comprises determining the coating quantity from the average weight of a formulation taken before and after the coating process.
  • Nonpatent Reference 1 relates to an in-line methodology that employs the near infrared spectrum to measure the thickness of a coating layer applied on a pellet.
  • Nonpatent Reference 2 discloses results that suggest the possibility of being able to predict the dissolution behavior of carbamazepine tablets by measurement of the near infrared spectrum.
  • Nonpatent Reference 1 Martin Andersson et al. "Quantitative Analysis of Film Coating in a Fluidized Bed Process by In-Line NIR Spectrometry and Multivariate Batch Calibration" Anal. Chem. 2000, 72, 2099-2108 .
  • Nonpatent Reference 2 Peter N. Zannikos et al. "Spectrophotometric Prediction of the Dissolution Rate of Carbamazepine Tablets” Pharmaceutical Research, 1991, 8, 974-978 .
  • the method of determining of coating quantity from the average weight of a formulation taken before and after the coating process carries out measurement after the measurement sample has been collected and is therefore unable to measure real-time changes in the coating quantity during production.
  • drug products employ a variety of ingredients other than the drug component itself, and the absorptions from various components overlap in the near infrared region where absorption for the molecular vibration of, for example, C-H, N-H, and O-H, is observed. Methods of evaluation that employ the near infrared spectrum therefore generally have a low specificity and in particular encounter difficulty in the evaluation of trace components.
  • Nonpatent References 1 and 2 use of near infrared spectroscopic measurements to evaluate coating quantity and predict dissolution behavior
  • the technology of Nonpatent Reference 1 in fact uses the near infrared in the long wavelength region (1100 to 2500 nm) of the near infrared region for its measurement wavelength. Absorption in the wavelength region has a stronger intensity than in the low wavelength region (400 to 1100 nm).
  • This is a region next to fundamental vibrations, there is a high possibility of overlap by combination tones of various vibrations and first and second overtones. The problem of a poor specificity therefore arises.
  • the long wavelength region (1100 to 2500 nm) of the near infrared is again used in Nonpatent Reference 2, and this report is also limited to the use of carbamazepine tablets as the measurement target.
  • the inventor of the present application unexpectedly discovered that the coating quantity can be very accurately measured, with little influence from interference due to peaks based on other components, by measurement using the 800 to 1100 nm wavelength region of the near infrared spectrum of, for example, granules or tablets coated with a coating liquid that contains, for example, polyethylene glycol and/or a long-chain hydrocarbyl-containing compound.
  • the present invention provides a method of measuring the quantity of a coating applied to a coating target, based on a measurement value obtained by measuring the absorption or scattering of light in the 800 to 1100 nm wavelength range by an additive coated on the coating target.
  • the present invention additionally provides a method of predicting the dissolution behavior of a pharmacologically effective ingredient from a coating target, based on the coating quantity obtained by the aforementioned method of coating quantity measurement.
  • the present invention further provides a method of measuring the quantity of a coating applied to a coating target, based on the absorption or scattering of light in the 800 to 1100 nm wavelength range by an additive coated on the coating target.
  • the present invention can use any additive that absorbs or scatters light in the 800 to 1100 nm wavelength range, for example, plasticizers, lubricants, fluidizers, colorants, stabilizers, masking agents, coating agents (coating material), and so forth.
  • a long-chain hydrocarbyl-containing compound can be used as the additive.
  • long-chain hydrocarbyl denotes a saturated or unsaturated hydrocarbon chain that contains at least 6 carbons, for example, cetyl, stearyl, and so forth.
  • Long-chain hydrocarbyl-containing compounds can be exemplified by higher alcohols, fatty acid esters, and fatty acid salts.
  • the higher alcohols can be specifically exemplified by tetradecanol, pentadecanol, cetyl alcohol, heptadecanol, nanodecanol, docosanol, and stearyl alcohol;
  • the fatty acid esters can be specifically exemplified by glycerol/fatty acid esters and sodium stearyl fumarate;
  • the fatty acid salts can be specifically exemplified by magnesium stearate and calcium stearate.
  • the long-chain hydrocarbyl-containing compounds usable by the invention of the present application are not limited to the preceding.
  • Polyethylene glycol can also be used as the additive in the present invention.
  • a variety of polyethylene glycols graded by molecular weight are commercially available, any of which may be used in the present invention. Among these, the use of Macrogol 4000, Macrogol 6000, Macrogol 20000, and so forth is preferred and the use of Macrogol 6000 is more preferred.
  • the present invention can be used regardless of the coating functionality as long as the coating liquid contains an additive that absorbs or disperses light in the 800 to 1100 nm wavelength region.
  • a taste-masking coating, gastric-dissolving coating, enteric-dissolving coating, sustained-release coating, other types of coatings in order to strengthen the chemical stability or physical strength of the formulation, and so forth can be used.
  • the near infrared radiation used by the present invention has a wavelength of 800 to 1100 nm.
  • the wavelength preferred therein is 900 to 960 nm while 920 to 950 nm is more preferred.
  • 920 to 940 nm is even more preferred when the evaluation is carried out using a long-chain hydrocarbyl-containing compound, while 930 to 950 nm is even more preferred when the evaluation is carried using polyethylene glycol.
  • This near infrared radiation can be generated by a tungsten lamp, halogen lamp, or other known means.
  • the detector used to detect this near infrared radiation can be a photoconductive detector of lead sulfide (PbS), a silicon (Si) photodetector, or another known detector.
  • the present invention is directed to measurement of the coating quantity of a granule or tablet coating target based on the spectrum in the near infrared region; thus, in addition to measurement based on the absorption spectrum, the coating quantity can be measured, for example, based on the spectrum of the near infrared region present in Raman-scattered light.
  • the test material that can be measured by the present invention can be exemplified by tablets and granules (including microparticulate formulations) comprising a particulate material, such as a granule coating target or uncoated tablets, on which a coating has been executed by a method such as, for example, film coating, powder coating, or press coating.
  • a method such as, for example, film coating, powder coating, or press coating.
  • the measurement method is not limited to diffuse reflection, transmission, and transmission reflection and other known techniques can also be used.
  • the calculation of the coating quantity and prediction of dissolution behavior are carried out in the present invention by the extraction from the near infrared region spectrum yielded by the test material of a mathematical relationship related to the coating quantity and the dissolution behavior.
  • the techniques used to extract such a mathematical relationship encompass preprocessing of the spectrum (e.g., normalization, difference spectrum, second derivative), multivariate analysis (e.g., multiple linear regression or MLR, principal component analysis or PCA, partial least squares or PLS), and other methods obtained by known means.
  • the invention of the present application carries out measurement using light in the 800 to 1100 nm wavelength range, it is able to carry out measurement of the coating quantity with little influence from interference by spectra based on other ingredient components.
  • the present invention because its measurement wavelength range is limited to the low wavelength region, can shorten the time required for measurement and can also lower the cost of the measurement instrumentation by enabling the use as the light source and/or detector of commercially available devices that operate in the ultraviolet region.
  • Test Example 1 Test of the measurement of the spectra of various ingredients
  • the near infrared absorption spectra in the near infrared region were measured on polyethylene glycol, long-chain hydrocarbyl-containing compounds, and various ingredients as used in pharmaceutical products.
  • the measurement results are given in Figure 4 in the neighborhood of the absorption region band for the fundamental vibrations based on long-chain hydrocarbyl groups; the results in the neighborhood of the absorption region band for first overtone vibrations are given in Figure 3; the results in the neighborhood of the absorption region band for second overtone vibrations are given in Figure 2; and the results in the neighborhood of the absorption region band for third overtone vibrations are given in Figure 1.
  • the measurement results are those of near-infrared spectrum treated by second derivative (secondary differential).
  • Peaks due to the long-chain hydrocarbyl-containing compounds (1-tetradecanol, 1-pentadecanol, cetyl alcohol, 1-heptadecanol, stearyl alcohol, 1-nanodecanol, 1-docosanol, glycerol/fatty acid esters, magnesium stearate, and sodium stearyl fumarate) and polyethylene glycol covered by the invention of the present application are indicated by thick lines, while peaks due to typical additives (hydroxypropyl methyl cellulose phthalate, hydroxypropyl cellulose, low degree of substitution hydroxypropyl cellulose, NP-103_32_42, NP-108[200], polyvinylpyrrolidone, crospovidone, crystalline cellulose, ethyl cellulose, methacrylic acid copolymer, corn starch, mannitol, talc, triethyl citrate, and titanium oxide) are indicated by thin lines.
  • the measurement conditions in this test example are
  • the coating quantity on tablets was evaluated using cetyl alcohol, a long-chain hydrocarbyl-containing compound that is generally used as a coating additive and whose use for pharmaceutical products has been recognized.
  • cetyl alcohol a long-chain hydrocarbyl-containing compound that is generally used as a coating additive and whose use for pharmaceutical products has been recognized.
  • 10 15, 20, 25, or 30 mg of a coating liquid containing the components shown in Table 3 was coated by film coating on uncoated tablets having the constituent components shown in Table 2.
  • the weight% of cetyl alcohol in the tablets was 0.46 to 1.37%.
  • the coating quantity was calculated for 15 tablets at each level by subtracting the average weight of the 15 tablets prior to coating from the tablet weight of each single tablet after coating.
  • the dissolution time was evaluated using the tablets employed in the preceding Test Example 2. These tablets were obtained by film coating 10, 15, 20, 25 or 30 mg of a coating liquid containing the components shown in Table 3 on uncoated tablets having the constituent components shown in Table 2, with the dissolution time of the pharmacologically effective component being controlled by the quantity of this film coating.
  • the relationship between the time required for the dissolution rate of the pharmacologically effective component from the tablet to reach 5% (lag time) and the coating quantity obtained in Test Example 2 was investigated in this test. The results are shown in Figure 6. The results are given for the execution of dissolution tests in 6 vessels, and the number of triangles in each case is 6.

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  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Pathology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Food Science & Technology (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Medicinal Preparation (AREA)
EP06713343A 2005-02-03 2006-02-02 Procédé de mesure de quantité d'enduction et procédé d'évaluation du comportement d'élution Withdrawn EP1857809A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2005027417 2005-02-03
PCT/JP2006/302200 WO2006083001A1 (fr) 2005-02-03 2006-02-02 Procédé de mesure de quantité d’enduction et procédé d’évaluation du comportement d’élution

Publications (2)

Publication Number Publication Date
EP1857809A1 true EP1857809A1 (fr) 2007-11-21
EP1857809A4 EP1857809A4 (fr) 2012-11-21

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EP06713343A Withdrawn EP1857809A4 (fr) 2005-02-03 2006-02-02 Procédé de mesure de quantité d'enduction et procédé d'évaluation du comportement d'élution

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Country Link
US (1) US8252362B2 (fr)
EP (1) EP1857809A4 (fr)
JP (1) JP4800295B2 (fr)
CN (1) CN101107510B (fr)
WO (1) WO2006083001A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
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EP3026391A1 (fr) * 2014-11-25 2016-06-01 Flooring Technologies Ltd. Procédé de détermination de la quantité d'une couche appliquée sur une plaque de support, en particulier d'une couche de fond

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WO2009144974A1 (fr) * 2008-05-29 2009-12-03 第一三共株式会社 Procédé de surveillance d'un état de mélange d'ingrédient lubrifiant dans une préparation médicinale
WO2010068906A1 (fr) * 2008-12-11 2010-06-17 Baxter International Inc. Détection de molécules de polymère acceptables physiologiquement au moyen de la spectroscopie proche infrarouge
JP6161867B2 (ja) 2011-11-17 2017-07-12 株式会社アドバンテスト 滑沢剤の展延解析装置、方法、プログラム、記録媒体
JP6408242B2 (ja) * 2013-04-22 2018-10-17 エーザイ・アール・アンド・ディー・マネジメント株式会社 コーティング剤の量の測定方法
JP6571436B2 (ja) * 2015-07-28 2019-09-04 株式会社ティーワイテクノ 粉体圧縮成形物の評価方法及び評価装置
EP3590510B1 (fr) * 2017-03-03 2022-05-04 San-Ei Gen F.F.I., INC. Préparation médicinale contenant de la curcumine et procédé d'évaluation des caractéristiques d'absorption ou d'élution de celle-ci
JP7137772B2 (ja) * 2017-11-07 2022-09-15 大日本印刷株式会社 検査システム、検査方法及び検査システムの製造方法
JP6930711B2 (ja) * 2017-11-20 2021-09-01 フロイント産業株式会社 錠剤測定装置
CN115436340B (zh) * 2022-11-08 2023-03-07 北京工业大学 一种无损、快速检测医用导管表面覆有功能涂层的方法

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3026391A1 (fr) * 2014-11-25 2016-06-01 Flooring Technologies Ltd. Procédé de détermination de la quantité d'une couche appliquée sur une plaque de support, en particulier d'une couche de fond
EP3757508A1 (fr) * 2014-11-25 2020-12-30 Flooring Technologies Ltd. Procédé de détermination de la quantité d'une couche appliquée sur une plaque porteuse, en particulier une couche d'apprêt

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Publication number Publication date
JPWO2006083001A1 (ja) 2008-06-26
JP4800295B2 (ja) 2011-10-26
EP1857809A4 (fr) 2012-11-21
WO2006083001A1 (fr) 2006-08-10
US20090269484A1 (en) 2009-10-29
US8252362B2 (en) 2012-08-28
CN101107510B (zh) 2010-05-19
CN101107510A (zh) 2008-01-16

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